As of September 30, 2011, the Company had no debt, and $100.4 million in total cash, cash equivalents and investments.Financial Guidance Allos is lowering prior operating expense guidance for full year 2011. Prior operating expense guidance for the full year 2011 was $95 to $98 million. Allos now expects total operating costs and expenses, excluding cost of sales, cost of license and other revenue and non-cash stock-based compensation expense, to approximate $82 to $84 million. Stock-based compensation expense for 2011 is now expected to approximate $12 million, as compared to prior guidance of $13 to $14 million. Allos expects that license and other revenue and cost of license and other revenue, related to the Mundipharma agreement for the fourth quarter 2011, should approximate $1.0 million and $0.5 million, respectively. This guidance relates to expected research and development and regulatory services to be performed, which includes Mundipharma’s current 40% share of jointly agreed-upon clinical development expenses for FOLOTYN. As of September 30, 2011, the Company had $100.4 million in total cash, cash equivalents and investments. The Company expects this cash position will be sufficient to fund operations through the end of 2014. This projection is based on historical sales levels for the first nine months of 2011 and the Company’s projected operating expenses through 2014. Achievement of growth in U.S. sales and/or potential milestone payments and royalties associated with regulatory approval of FOLOTYN in the EU would further extend the Company’s cash resources. Actual financial results will vary based upon many factors, including the amount of FOLOTYN sales and rate of patient enrollment in ongoing clinical trials of FOLOTYN. Recent Corporate Events
- On October 21, 2011, the Agreement and Plan of Merger and Reorganization (“the Merger Agreement”) entered into by and among Allos, AMAG Pharmaceuticals, Inc. and Alamo Acquisition Sub, Inc. on July 19, 2011, as amended on August 8, 2011, was terminated following a special meeting of stockholders. Allos' stockholders voted in favor of the adoption of the Merger Agreement; AMAG stockholders voted against the proposed merger. Pursuant to the terms of the Merger Agreement, AMAG paid Allos on October 25, 2011 a net expense reimbursement amount equal to $1.8 million in connection with such termination.
- In August 2011, Allos enrolled the first patient in a Phase 3 randomized clinical trial (PDX-017) evaluating FOLOTYN in patients with first-line peripheral T-cell lymphoma (PTCL). This study is open to enroll newly diagnosed patients with PTCL who have achieved an objective response following initial treatment with CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone) or a CHOP-like regimen. Earlier this year, Allos reached agreement with the U.S. Food and Drug Administration under its Special Protocol Assessment (SPA) process on the design of this Phase 3 trial.